Clinical Scientist, Oncology jobs in United States
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Corcept Therapeutics · 1 day ago

Clinical Scientist, Oncology

Corcept Therapeutics is leading the research and development of cortisol modulators to treat serious diseases. The Clinical Scientist will ensure the clinical and scientific integrity of clinical trials conducted by Corcept in the Oncology therapeutic area.

BiotechnologyMedicalPharmaceutical
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Comp. & Benefits
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Responsibilities

Act as clinical scientist and clinical subject matter expert for both Company team members and for external contacts related to the assigned therapeutic programs
Provide training and ongoing input to all members of the clinical team on medical and scientific issues related to the therapeutic field in question
Provide scientific oversight for Company operational staff, contract research organizations (CROs), and clinical trial sites in all areas related to the therapeutic programs
Collaborate in the writing and review of protocols, investigator brochures, study reports and other clinical and regulatory documents
Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems and final reports
Acts to provide clinical oversight and contributes to safety monitoring for ongoing clinical trials including participation in SAE reporting and serving on the safety committee
Play a key role in the analysis, interpretation and delivery of high-quality clinical data
Interact with principal investigators and opinion leaders to facilitate clinical trials research
Participate in appropriate regulatory discussion and activities, including the filing of IND’s, CTXs, NDA/MAAs, throughout the development cycle
Participate in clinical study report conceptualization, development and writing for global regulatory submissions
Work closely and collaboratively with other functions, e.g. clinical operations, safety, biometrics, regulatory, medical writing, medical affairs and commercial
Develop and give internal and external presentations as subject matter expert for the therapeutic area
Participate in the development and review of publications
Prepare and monitor budgets in collaboration with clinical operations and R&D finance
Serve as liaison to the commercial team on scientific issues

Qualification

Clinical trial oversightOncology expertiseScientific writingClinical development experienceRegulatory submissionsCommunicatorLeadership skillsCross-functional collaborationFast-paced adaptability

Required

Act as clinical scientist and clinical subject matter expert for both Company team members and for external contacts related to the assigned therapeutic programs
Provide training and ongoing input to all members of the clinical team on medical and scientific issues related to the therapeutic field in question
Provide scientific oversight for Company operational staff, contract research organizations (CROs), and clinical trial sites in all areas related to the therapeutic programs
Collaborate in the writing and review of protocols, investigator brochures, study reports and other clinical and regulatory documents
Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems and final reports
Acts to provide clinical oversight and contributes to safety monitoring for ongoing clinical trials including participation in SAE reporting and serving on the safety committee
Play a key role in the analysis, interpretation and delivery of high-quality clinical data
Interact with principal investigators and opinion leaders to facilitate clinical trials research
Participate in appropriate regulatory discussion and activities, including the filing of IND's, CTXs, NDA/MAAs, throughout the development cycle
Participate in clinical study report conceptualization, development and writing for global regulatory submissions
Work closely and collaboratively with other functions, e.g. clinical operations, safety, biometrics, regulatory, medical writing, medical affairs and commercial
Develop and give internal and external presentations as subject matter expert for the therapeutic area
Participate in the development and review of publications
Prepare and monitor budgets in collaboration with clinical operations and R&D finance
Serve as liaison to the commercial team on scientific issues
Strong clinical and scientific knowledge
Excellent communicator with proven leadership skills and the ability to interact in a cross functional environment
Comfortable in a fast-paced and nimble small company environment and able to adjust workload based upon changing priorities
Pharm D, PhD, MD or equivalent, preferably with experience in oncology therapeutic area(s)
0-2+ years of relevant clinical development experience is preferred
Relevant clinical research experience in academic settings is desirable
Applicants must be currently authorized to work in the United States on a full-time basis

Company

Corcept Therapeutics

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Corcept Therapeutics discovers and develops drugs that regulate the effects of cortisol.

Funding

Current Stage
Public Company
Total Funding
$119.09M
Key Investors
Paperboy Ventures
2012-07-02IPO
2012-04-10Post Ipo Equity· $0.53M
2011-01-21Post Ipo Equity· $39M

Leadership Team

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Roberto Vieira
President, Oncology
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Yuan Xu
Associate Director, Statistical Programming
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Company data provided by crunchbase